Atherectomy system

ABSTRACT

Medical systems and methods for making and using medical systems are disclosed. Example medical systems may include an atherectomy system configured to engage and remove plaque from walls in vessels of a vascular system. The atherectomy system may include a drive shaft, a rotational tip coupled to an end of the drive shaft, a drive mechanism coupled to the drive shaft to rotate the rotational tip, a control unit configured to control operation of the drive mechanism, and a knob assembly configured to facilitate longitudinal movement of the drive shaft, the rotational tip, and/or the drive mechanism. In some cases, the knob assembly may be configured to initiate adjustment of a mode of the drive mechanism in response to actuation of an actuator in the knob assembly.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of priority under 35 U.S.C. § 119 ofU.S. Provisional Application No. 62/613,023, filed Jan. 2, 2018, theentire disclosure of which is hereby incorporated by reference.

TECHNICAL FIELD

The present disclosure pertains to medical devices, and methods formanufacturing and using medical devices. More particularly, the presentdisclosure pertains to rotational medical devices, methods, and systems,including those with drive mechanisms and actuation controls.

BACKGROUND

A wide variety of medical devices have been developed for medical use,for example, for use in accessing body cavities and interacting withfluids and structures in body cavities. Some of these devices mayinclude guidewires, catheters, pumps, motors, controllers, filters,grinders, needles, valves, and delivery devices and/or systems used fordelivering such devices. These devices are manufactured by any one of avariety of different manufacturing methods and may be used according toany one of a variety of methods. Of the known medical devices andmethods, each has certain advantages and disadvantages.

BRIEF SUMMARY

This disclosure provides, design, material, manufacturing method, anduse alternatives for medical devices and systems. In a first aspect, anatherectomy device may include a housing, a drive mechanism positionedwithin the housing and configured to couple to an elongate member androtate the elongate member upon actuation, a knob assembly incommunication with the drive mechanism and operably accessible fromexterior the housing, the knob assembly may be configured tolongitudinally translate to adjust an axial position of the drivemechanism, and be actuated to selectively adjust the drive mechanismbetween an on mode and an off mode.

In addition or alternative and in a second aspect, the knob assembly maybe configured to longitudinally translate along a fixed longitudinaldistance and be releasably engaged with the housing to fix the drivemechanism at a location along the fixed longitudinal distance.

In addition or alternative and in a third aspect, the knob assembly maycomprise an actuator that is actuated to selectively adjust the drivemechanism between the on mode and the off mode.

In addition or alternative and in a fourth aspect, the knob assembly maycomprise a switch configured to facilitate adjusting the drive mechanismbetween the on mode and the off mode, and an actuator configured toengage the switch in response to being actuated, the actuator engagesthe switch to adjust the drive mechanism between the on mode and the offmode.

In addition or alternative and in a fifth aspect, the knob assembly maycomprise a slide adaptor coupled to the drive mechanism, a knob bodycoupled to the slide adaptor and configured to releasably engage thehousing to fix the drive mechanism at an axial location along thehousing, and an actuator configured to be actuated to selectively adjustthe drive mechanism between the on mode and the off mode.

In addition or alternative and in a sixth aspect, the knob assembly maycomprise a switch configured to axially translate with the drivemechanism and facilitate adjusting the drive mechanism between the onmode and the off mode, and wherein the actuator is configured to engagethe switch in response to being actuated.

In addition or alternative and in a seventh aspect, the knob assemblymay comprise a printed circuit board in electrical communication withthe switch and coupled with the slide adaptor.

In addition or alternative and in an eighth aspect, the device mayfurther comprise a control assembly configured to control power to thedrive mechanism, and the knob assembly may comprise a printed circuitboard in electrical communication with the switch and configured toaxially translate with the drive mechanism, the printed circuit board isin electrical communication with the control assembly.

In addition or alternative and in a ninth aspect, the actuator may becoupled to the slide adaptor and configured to translate with the drivemechanism between a first axial position of the drive mechanism and asecond axial position of the drive mechanism.

In addition or alternative and in a tenth aspect, the knob body may becoupled to the slide adaptor via a first connection and a secondconnection, the knob body may be configured to be adjusted via thesecond connection to selectively engage the housing and fix the drivemechanism at the axial location along the housing.

In addition or alternative and in an eleventh aspect, the drivemechanism may be a turbine.

In addition or alternative and in a twelfth aspect, a method ofactuating an atherectomy device of an atherectomy system may comprisereleasing a knob assembly from a releasably fixed position at a locationon a predetermined path along a housing of the atherectomy device,actuating an actuator of the knob assembly to initiate an on mode of adrive mechanism in the housing of the atherectomy device, andlongitudinally translating the knob assembly on the predetermined path.

In addition or alternative and in a thirteenth aspect, the method mayfurther comprise when the drive mechanism is in the on mode, actuatingthe actuator of the knob assembly to initiate an off mode of the drivemechanism.

In addition or alternative and in a fourteenth aspect, the actuator maybe actuated while the knob assembly is fixed at the location on thepredetermined path.

In addition or alternative and in a fifteenth aspect, the actuator maybe actuated while the knob assembly is released from the releasablyfixed position.

In addition or alternative and in a sixteenth aspect, the method mayfurther comprise rotating a knob body of the knob assembly until theknob body engages the housing of the atherectomy device to releasablyfix the knob assembly relative to the housing.

In addition or alternative and in a seventeenth aspect, an atherectomydevice may comprise a drive mechanism configured to rotate an elongatemember securable to the drive mechanism, a knob assembly comprising aslide adaptor secured relative to the drive mechanism, a knob bodyadjustably secured to the slide adaptor, and an actuator adjustablysecured to the slide adaptor, and wherein the knob assembly may beconfigured to longitudinally translate with the drive mechanism andactuation of the actuator may initiate a mode of the drive mechanism.

In addition or alternative and in an eighteenth aspect, the knobassembly may comprise a switch in communication with the actuator suchthat actuation of the actuator adjusts the switch to initiate a mode ofthe drive mechanism.

In addition or alternative and in a nineteenth aspect, the knob assemblymay comprise a printed circuit board coupled to the slide adaptor and inelectrical communication with the switch.

In addition or alternative and in a twentieth aspect, the knob body maybe adjustable between a first position that facilitates longitudinaltranslation of the drive mechanism and a second position that releasablyfixes the drive mechanism at a longitudinal location and the actuator isactuatable to initiate a mode of the drive mechanism when the knob bodyis in the first position and when the knob body is in the secondposition.

The above summary of some embodiments is not intended to describe eachdisclosed embodiment or every implementation of the present invention.The Figures, and Detailed Description, which follow, more particularlyexemplify these embodiments.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention may be more completely understood in consideration of thefollowing detailed description of various embodiments of the inventionin connection with the accompanying drawings, in which:

FIG. 1 is a schematic diagram of an example atherectomy system;

FIG. 2 is a schematic exploded view of an example knob assembly for anatherectomy system;

FIG. 3 is a schematic flow diagram of an example method of assembling aknob assembly;

FIG. 4 is a schematic perspective view of a portion of an exampleadvancer assembly with a knob assembly in an exploded configuration;

FIG. 5 is a schematic cross-section view of a portion of an exampleadvancer assembly; and

FIG. 6 is a schematic flow diagram of an example method of using anatherectomy system.

While the disclosure is amenable to various modifications andalternative forms, specifics thereof have been shown by way of examplein the drawings and will be described in detail. It should beunderstood, however, that the intention is not to limit the invention tothe particular embodiments described. On the contrary, the intention isto cover all modifications, equivalents, and alternatives falling withinthe spirit and scope of the disclosure.

DETAILED DESCRIPTION

For the following defined terms, these definitions shall be applied,unless a different definition is given in the claims or elsewhere inthis specification.

All numeric values are herein assumed to be modified by the term“about”, whether or not explicitly indicated. The term “about” generallyrefers to a range of numbers that one of skill in the art would considerequivalent to the recited value (e.g., having the same function orresult). In many instances, the terms “about” may include numbers thatare rounded to the nearest significant figure.

The recitation of numerical ranges by endpoints includes all numberswithin that range (e.g. 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and5).

As used in this specification and the appended claims, the singularforms “a”, “an”, and “the” include plural referents unless the contentclearly dictates otherwise. As used in this specification and theappended claims, the term “or” is generally employed in its senseincluding “and/or” unless the content clearly dictates otherwise.

It is noted that references in the specification to “an embodiment”,“some embodiments”, “other embodiments”, etc., indicate that theembodiment described may include one or more particular features,structures, and/or characteristics. However, such recitations do notnecessarily mean that all embodiments include the particular features,structures, and/or characteristics. Additionally, when particularfeatures, structures, and/or characteristics are described in connectionwith one embodiment, it should be understood that such features,structures, and/or characteristics may also be used in connection withother embodiments whether or not explicitly described unless clearlystated to the contrary.

The following detailed description should be read with reference to thedrawings in which similar elements in different drawings are numberedthe same. The drawings, which are not necessarily to scale, depictillustrative embodiments and are not intended to limit the scope of theinvention.

Cardiovascular disease and peripheral arterial disease may arise fromaccumulation of atheromatous material on the inner walls of vascularlumens, resulting in a condition known as atherosclerosis. Atheromatousand other vascular deposits may restrict blood flow and can causeischemia in a heart of a patient, vasculature of a patient's legs, apatient's carotid artery, etc. Such ischemia may lead to pain, swelling,wounds that will not heal, amputation, stroke, myocardial infarction,and/or other conditions.

Atheromatous deposits may have widely varying properties, with somedeposits being relatively soft and others being fibrous and/orcalcified. In the latter case, the deposits may be referred to asplaque. Atherosclerosis occurs naturally as a result of aging, but mayalso be aggravated by factors such as diet, hypertension, heredity,vascular injury, and the like. Atherosclerosis may be treated in avariety of ways, including drugs, bypass surgery, and/or a variety ofcatheter-based approaches that may rely on intravascular widening orremoval of the atheromatous or other material occluding the bloodvessel. Atherectomy is a catheter-based intervention that may be used totreat atherosclerosis.

Atherectomy is an interventional medical procedure performed to restorea flow of blood through a portion of a patient's vasculature that hasbeen blocked by plaque or other material. In an atherectomy procedure, adevice on an end of a drive shaft is used to engage and/or remove (e.g.,abrade, grind, cut, shave, etc.) plaque or other material from apatient's vessel (e.g., artery or vein). In some cases, the device on anend of the drive shaft may be abrasive and/or may otherwise beconfigured to remove plaque from a vessel wall or other obstruction in avessel when the device is rotating and engages the plaque or otherobstruction.

FIG. 1 depicts an atherectomy system 10. The atherectomy system 10 mayinclude a drive assembly 12 (e.g., an atherectomy device) and a controlunit 14 (e.g., a controller or control console). Although the driveassembly 12 and the control unit 14 are depicted in FIG. 1 as separatecomponents of the atherectomy system 10, the features of the controlunit 14 may be incorporated into the drive assembly 12.

The drive assembly 12 may include, among other elements, an advancerassembly 16, a drive shaft 18 (e.g., a flexible drive shaft or otherdrive shaft), a rotational device 20 (e.g., a rotational tip or otherrotational device), and an elongated member 22 having a first end (e.g.,a proximal end), a second end (e.g., a distal end), and a lumenextending from the first end to the second end for receiving the driveshaft 18. In some cases, the elongated member 22 may be an elongatedtubular member. The rotational device 20 may have a rough or sharpsurface, such that it is configured to grind, abrade, cut, shave, etc.plaque from a vessel wall or other obstruction in a vessel when it isrotated.

The advancer assembly 16 may include an advancer knob assembly 23 andmay house a drive mechanism (e.g., the drive mechanism 50 shown in FIG.5; the drive mechanism may be a turbine, an electric motor, pneumaticmotor, and/or one or more other suitable drive mechanisms) incommunication with the advancer knob assembly 23 and the drive shaft 18.The advancer knob assembly 23 may be configured to translate along alongitudinal path to longitudinally advance and/or retract the drivemechanism, the drive shaft 18, and/or and the rotational device 20,secure the drive mechanism at an axial location along the longitudinalpath, and/or adjust a mode of the drive mechanism.

Although the drive mechanism is described herein as being included inthe advancer assembly 16, it is contemplated that the drive mechanismmay be separate from, but in communication with the advancer assembly16. In such cases, the knob assembly 23 may be utilized to advance thedrive mechanism, the drive shaft 18, and/or the rotational device 20 andinitiate actuation of a mode of the drive mechanism.

The drive mechanism may be coupled to the drive shaft 18 in a suitablemanner including, but not limited to a weld connection, a clampingconnection, an adhesive connection, a threaded connection, and/or othersuitable connection configured to withstand high rotational speeds andforces. As the drive shaft 18 may rotate over a wide range of speeds(e.g., at speeds of between zero (0) rotations per minute (RPM) and250,000 RPM or higher in a clockwise and/or counterclockwise direction),the coupling between the drive mechanism and the drive shaft 18 may beconfigured to withstand such rotational speed and associated forces.

In some cases, the drive mechanism may be in communication with thecontrol unit 14. When in communication with the control unit 14, thedrive mechanism may be in direct communication with the control unit(e.g., directly connected via wiring) or indirect communication (e.g.,indirectly connected via multiple wiring connections and/or one or moredevices). One example of indirect communication between a drivemechanism and the control unit 14 may include a drive mechanism (e.g., aturbine or pneumatic motor) powered by compressed air, where the controlunit 14 may activate a compressed fluid flow from a cylinder 25 or othercomponent to the drive mechanism (e.g., activate a valve of the controlunit 14 or otherwise activate the compressed fluid flow), which mayresult in rotation of the drive mechanism and the drive shaft 18.

The drive shaft 18 may be formed from one or more of a variety ofmaterials. For example, the drive shaft 18 may be formed from one ormore of a variety of materials including steel, stainless steel, and/orother suitable materials.

The drive shaft 18 may have a suitable diameter and/or length fortraversing vasculature of a patient. In some cases, the drive shaft 18may have a diameter in a range from about 0.030 centimeters (cm) orsmaller to about 0.150 cm or larger and a working length in a range fromabout ten (10) cm or shorter to about three hundred (300) cm or longer.Alternatively, the drive shaft 18 may have a different suitable diameterand/or a different suitable length.

The rotational device 20 may have an outer perimeter which is equal toor larger than a distal diameter of the drive shaft 18 and the elongatedmember 22. The rotational device 20 may have a symmetric design so thatit penetrates equally well in both rotational directions, but this isnot required and the rotational device 20 may be configured to penetratein only one direction. The diameter of the drive shaft 18 may depend onthe dimension of the lumen of the elongated member 22 and/or one or moreother factors.

The rotational device 20 may be coupled to the drive shaft 18. Where thedrive shaft 18 has a first end portion (e.g., a proximal end portion)and a second end portion (e.g., a distal end portion), the rotationaldevice 20 may be coupled to the drive shaft 18 at or near the second endportion. In some cases, the rotational device 20 may be located at oradjacent a terminal end of the second end portion of the drive shaft 18.

The rotational device 20 may be coupled to the drive shaft 18 in anymanner. For example, the rotational device 20 may be coupled to thedrive shaft 18 with an adhesive connection, a threaded connection, aweld connection, a clamping connection, and/or other suitable connectionconfigured to withstand high rotational speeds and forces. Similar to asdiscussed above with respect to the connection between the drive shaft18 and the drive mechanism, as the drive shaft 18 and/or the rotationaldevice 20 may rotate at speeds between zero (0) RPM and 250,000 RPM orhigher in a clockwise direction, a counter clockwise direction, or botha clockwise direction and a counter clockwise direction, the couplingbetween the drive shaft 18 and the rotational device 20 may beconfigured to withstand such rotational speeds and associated forces.

The drive assembly 12 and the control unit 14 may be in communicationand may be located in or may have a same housing and/or located in orhave separate housings (e.g., an advancer assembly housing 26 and acontrol unit housing 28, respectively, or other housings). Whether inthe same housing or in separate housings, the drive assembly 12 and thecontrol unit 14 may be in communication through a wired (e.g., via oneor more electrical lines 24) and/or a wireless connection. Wiredconnections may be made via one or more communication protocolsincluding, but not limited to, USB, Ethernet, SPI, UART, HDMI, and/orany other suitable common or proprietary wired protocol, as desired.Wireless connections may be made via one or more communication protocolsincluding, but not limited to, cellular communication, ZigBee,Bluetooth, WiFi, IrDA, dedicated short range communication (DSRC),EnOcean, and/or any other suitable common or proprietary wirelessprotocol, as desired.

Although not necessarily shown in FIG. 1, the drive assembly 12 mayinclude and/or enclose one or more operational features in addition tothose discussed above and/or as alternatives to those discussed above.For example, among other features, the drive assembly 12 may includecontrol buttons, rubber feet, control electronics, drive circuitry, etc.

The control unit 14, which may be separate from the drive assembly 12(e.g., as shown in FIG. 1) or may be included in the drive assembly 12,may include several features. For example, as shown in FIG. 1, thecontrol unit 14 may include a display 30 and a control knob 32 (e.g., adrive mechanism speed (e.g., RPM or other speed) adjustment knob orother control knob). Additionally or alternatively, the control unit 14may include one or more other features for controlling the drivemechanism and/or other features of the drive assembly 12 (e.g., one ormore drive mechanism states) including, but not limited to, a processor,memory, input/output devices, a speaker, volume control buttons, on/offpower supply switch, drive mechanism mode activation switch, a timer, aclock, and/or one or more other features.

The display 30 may be or may include any suitable type of display panelusing any suitable display panel technology. For example, the display 30may include one or more of the following types of display panels:Eidophor, Electroluminescent display (ELD), Electronic paper (E Ink,Gyricon), Light emitting diode display (LED), Cathode ray tube (CRT)(Monoscope), Liquid-crystal display (LCD) (TFT, LED, Blue Phase, IPS),Plasma display panel (PDP) (ALiS), Digital Light Processing (DLP),Liquid crystal on silicon (LCoS), Organic light-emitting diode (OLED)(AMOLED), Organic light-emitting transistor (OLET), Surface-conductionelectron-emitter display (SED), Field emission display (FED), Laser TV(Quantum dot, Liquid crystal), MEMS display (IMoD, TMOS, DMS), Quantumdot display (QD-LED), Ferro liquid display (FLD), Thick-film dielectricelectroluminescent technology (TDEL), Telescopic pixel display (TPD),Laser Phosphor Display (LPD), or other type of display panel. Thedisplay 30 may include a touch sensitive screen for receiving input, butthis is not required.

The control knob 32 may be any suitable type of control knob. Asdepicted in FIG. 1, the control knob 32 may be a physical control knobthat is adjusted (e.g., rotated or otherwise translated) to adjust acontrol feature (e.g., speed of rotation of the drive mechanism or othercontrol feature). Alternatively or in addition, the control knob 32 maybe physical buttons, a virtual control knob that may be adjusted byinteracting with a touch sensitive surface, and/or other suitablecomponent configured to be adjusted to adjust a control feature.

As depicted in FIG. 1, the control unit 14 may include one or more portsincluding, but not limited to, a fiber optic port 34, an electrical port36, a fluid port 38, and/or one or more other ports. The fiber opticport 34 may be configured to receive a fiber optic connector 40 of afiber optic line 42, where the fiber optic line 42 may be connected toand/or may be part of a position sensor configured to optically sense aposition of the drive mechanism. Additionally or alternatively, othertypes of position sensors (e.g., tachometers) may be utilized that havedifferent types of connections to the control unit 14. The electricalport 36 may be configured to receive an electrical connector 44 of theelectrical line 24, where the electrical line 24 may be connected toand/or may be part of control electronics at the drive assembly 12. Insome cases, the electrical line 24 may be directly connected to a mainPCB of the drive assembly 12 and may be utilized to power an electricalassembly of the drive assembly 12. The fluid port 38 may be configuredto receive a fluid line connector 46 of a fluid line 48, where the fluidline 48 may be in communication with the drive mechanism to power thedrive mechanism. In instances when the drive mechanism is an electricalmotor or a non-pneumatic drive mechanism, the fluid port 38, the fluidline connector 46, and/or the fluid line 48 may be omitted, but this isnot required.

FIG. 2 depicts a schematic exploded perspective view of the knobassembly 23. In some cases, the knob assembly 23 may include a slideadaptor 52, a knob body 54, an actuator 56 and/or one or more othercomponents. The knob body 54 of the knob assembly 23 may receive theslide adaptor 52 and may be configured to be secured to or relative tothe slide adaptor 52. Each component (e.g., the slide adaptor 52, theknob body 54, the actuator 56, and/or other component) of the knobassembly 23 may be unitarily formed or formed from two or more componentparts fitted together in a suitable manner.

The knob body 54 may be secured to or relative to the slide adaptor 52in a suitable manner. For example, the knob body 54 may be secured to orrelative to the slide adaptor 52 via a snap connection, a threadedconnection, a keyed fit connection, a friction fit connection, and/orother suitable connection. In the example knob assembly 23 depicted inFIG. 2, the knob body 54 may be connectable to the slide adaptor 52 viaa first connection and a second connection, however, only a singleconnection may be utilized or more than two connections may be utilized.

In some cases, the first connection may be configured to facilitatesecuring the knob body 54 relative to the slide adaptor 52 whileallowing the knob body 54 to axially translate along an axis and/orrotate about the axis relative to the slide adaptor 52. In some cases,the first connection may be a snap connection between the knob body 54and the slide adaptor 52 and/or other connection that allows axialtranslation and/or rotation of the knob body 54 relative to the slideadaptor 52 after connecting the knob body 54 and the slide adaptor 52.When the first connection is a snap connection, the slide adaptor 52 mayinclude one or more engagement elements (e.g., four engagement elements58, such as flexible and/or resilient prongs, as shown in FIG. 2 orother suitable engagement elements) that may be configured to engage oneor more shoulders of the knob body 54 (e.g., shoulder 60 as shown inFIG. 2 or other suitable shoulder(s)) and allow the knob body 54 totranslate relative to the slide adaptor 52.

The second connection may be configured to facilitate releasably fixingthe knob assembly at a position along a predetermined path (e.g., afixed or adjustable longitudinal path) over which the knob assembly 23may be configured to translate (e.g., longitudinally translate) toadjust an axial position of the drive mechanism, drive shaft 18, and/orrotational device 20. In some cases, the second connection may be athreaded connection between the knob body 54 and the slide adaptor 52 orother connection configured to adjust for selectively fixing the knobassembly 23 at a position along a predetermined path. When the secondconnection is a threaded connection, threads on knob body 54 (e.g.,inner threads 62 as shown in FIG. 5 or other threads) may engage threadson the slide adaptor 52 (e.g., outer threads 64 as shown in FIGS. 2, 4,and 5 or other threads).

The actuator 56 may be inserted through a central opening or otheropening of the knob body 54 and/or the slide adaptor 52. The actuator 56may be secured in the knob assembly 23 (e.g., at least partially withinthe openings extending within the knob body 54 and the slide adaptor 52)in a suitable manner. In some cases, the actuator 56 may be secured inthe knob assembly 23 such that it may be adjusted or actuated byinteracting with a first end 56 a of the actuator 56 (e.g., by pressingon a surface at the first end 56 a) to allow a second end 56 b of theactuator 56 to engage a switch or other electrical or electromechanicalcomponent.

The actuator 56 may be secured relative to the knob body 54 and/or theslide adaptor 52 by engaging one or both of the knob body 54 and theslide adaptor 52. As shown in FIG. 3, the actuator 56 may include aprotrusion 66 configured to engage the engagement element 58 (e.g.,engage a catch 68 or other feature of the engagement element 58) of theslide adaptor 52 and slide within an opening 70 in the slide adaptor 52(e.g., in some cases, the opening 70 may be an opening betweenengagement elements 58). Alternatively or in addition, one or more bothof the actuator 56 and the slide adaptor 52 may include an indent oropening for engaging a protrusion of the other one of actuator 56 andthe slide adaptor 52.

The knob assembly 23 may include a switch 72, as shown in FIG. 2,configured to initiate a mode of operation of the drive mechanism. Insome cases, the switch 72 may be mechanically affixed and in electricalcommunication with a switch printed circuit board (PCB) 74 to form aswitch assembly. The switch 72 may be mechanically affixed and/or inelectrical communication with the switch PCB 74 in any suitable manner.In some cases, the switch 72 may be mechanically affixed and/orelectrically connected to the switch PCB 74 through one or moreconnection mechanisms including, but not limited to, solder, adhesive,welding, wire bonds, etc. Alternatively or in addition, the switchassembly may take on one or more other configurations, one or moreadditional or alternative electrical components, and/or one or moreadditional or alternative mechanical components.

Although it is not shown in the FIGs., the switch 72 and/or the switchPCB 74 may be in electrical communication with (e.g., electricallyconnected to and/or in other suitable electrical communication with) amain PCB of the drive assembly 12 for sending electrical signals to themain PCB and/or drive mechanism controller that are configured to adjusta mode of the drive mechanism. Alternatively or in addition, the switch72 may be directly electrically connected to the drive mechanism (e.g.,when the drive mechanism is an electric motor and/or in otherconfigurations) to adjust a mode of the drive mechanism in response tothe switch 72 being actuated by the actuator 56 and/or actuated in othersuitable manners.

The switch 72 may have a suitable configuration for adjusting a mode ofthe drive mechanism in response to be actuated by the actuator 56. Insome cases, the switch 72 may include a body 76 and a button 78. Thebutton 78 may be configured to translate relative to the body 76 inresponse to being actuated. For example, when the switch 72 ispositioned within the knob assembly 23, the second end 56 b of theactuator 56 may interact with the button 78 of the switch 72 to initiateadjusting a mode of the drive mechanism.

The switch 72 may operate in any suitable manner for adjusting a mode ofthe drive mechanism. In one example, the switch 72 may send a pulse to adrive mechanism controller (not shown) each time the actuator 56interacts with the switch. The drive mechanism controller may theneither initiate placing the drive mechanism to an on mode when a pulseis received and the drive mechanism was in an off mode at the time ofreceiving the pulse or initiate placing the drive mechanism to an offmode when a pulse is received and the drive mechanism was in an on modeat the time of receiving the pulse. Alternatively or in addition, theswitch 72 may operate in a different manner and may be configured tofacilitate adjusting one or more other control parameters of the drivemechanism in response to being actuated by the actuator 56. Further,although the switch 72 is described herein as sending pulses to a drivemechanism controller, the switch 72 may take one or more other suitableactions or provide one or more other suitable outputs in response tobeing actuated by the actuator 56.

When included in the knob assembly 23, the switch 72 may be positionedwithin the knob assembly 23, such that the second end 56 b of theactuator 56 may interact with the switch 72. In one example, the switch72 may be positioned in a receiving slot 80 of the slide adaptor 52. Theswitch 72 may be secured within the receiving slot 80 or otherwisesecured relative to the slide adaptor 52 though one or more connectionmechanisms including, but not limited to, a friction fit in thereceiving slot 80, a keyed fit connection, a luer lock connection, asnap fit in the receiving slot 80, adhesive, welding, soldering, apermanent connection, a releasable connection, and/or other suitableconnection mechanisms.

FIG. 3 depicts a method 100 of assembling a knob assembly 23 having aslide adaptor (e.g., the slide adaptor 52 or other suitable slideadaptor), a knob body (e.g., the knob body 54 or other suitable knobbody), an actuator (e.g., the actuator 56 or other suitable actuator),and a switch (e.g., the switch 72 or other suitable switch). The method100 may include positioning 102 the switch on the slide adaptor. Asdiscussed above with respect to the switch 72, the switch may bepositioned on the slide adaptor in a receiving slot (e.g., the receivingslot 80) or other recess configured to receive the switch and associatedcomponents (e.g., the switch PCB 74 and/or other components). Althoughnot necessarily required, the combined slide adaptor and switch may thenbe coupled with a drive mechanism (e.g., the drive mechanism 50 depictedin FIG. 5 or other suitable drive mechanism) to the extent the slideadaptor is separate from the drive mechanism and the slide adaptor maybe positioned within a housing (e.g., the housing 26 or other suitablehousing) of an advancer assembly (e.g., the advancer assembly 16 orother suitable advancer assembly). The slide adaptor positioned withinthe housing of the advancer assembly may be configured to extend throughan opening of the housing, but this is not required.

The method 100 may further include coupling 104 the knob body to theslide adaptor. In one example, the knob body may be coupled to the slideadaptor by threading on the knob body engaging threading on the slideadaptor. To further or alternatively couple the knob body to the slideadaptor and prevent or limit separation of the knob body and the slideadaptor, a force may be applied to one or both of the knob body and theslide adaptor to snap or otherwise connect the knob body onto the slideadaptor.

The actuator of the knob assembly may be aligned 106 with the switch toensure actuation of the actuator will cause actuation of the switch. Insome cases, the actuator may be aligned with the switch by inserting theactuator through openings extending through the knob body and/or theslide adaptor. Once aligned with the switch, the actuator may be coupled108 with the slide adaptor. In some cases, a force may be applied to oneor both of the knob body and the slide adaptor to snap or otherwiseconnect the knob body onto the slide adaptor. When the knob assembly ispositioned relative to the housing and assembled, a user may interactwith the knob assembly to longitudinally translate an axial position ofthe drive mechanism, a drive shaft (e.g., the drive shaft 18 or othersuitable drive shaft) coupled to the drive mechanism, and/or arotational device (e.g., the rotational device 20 or other suitablerotational device) coupled to the drive shaft, and fix the drivemechanism, the drive shaft, and/or the rotational device at a positionrelative to the housing of the advancer assembly, while allowing foradjustment of a mode of the drive mechanism through actuation of theactuator.

FIG. 4 depicts a schematic perspective view of the advancer assembly 16with a partially exploded view of the knob assembly 23 positioned withinand extending through the housing 26, where part of the advancerassembly 16 is cut-away. As shown in FIG. 4, the slide adaptor 52 mayextend through an opening 82 in the housing 26. After positioning theslide adaptor 52 in the housing 26 and extending the slide adaptor 52through the opening 82, the knob body 54 and/or the actuator 56 may becoupled to each other and/or the slide adaptor 52, as discussed herein(e.g., see steps 104, 106, and 108 of the method 100) or in one or moreother manners. Although the slide adaptor 52 described herein may beconfigured to extend through the opening 82, it is conceived that theknob body 54 and/or the actuator 56 may extend through the opening 82and coupled to the slide adaptor 52 at a location within the housing 26and/or the knob assembly 23 may take on one or more other configurationsconfigured to perform the functions of the knob assembly 23 describedherein.

The opening 82 of the housing 26 may have a suitable configuration forlongitudinally translating the drive mechanism, the drive shaft 18,and/or the rotational device 20. As shown in FIG. 4, the opening 82 hasan elongated shape and is configured to allow the knob assembly 23 tolongitudinally translate along a predetermined path (e.g., apredetermined fixed path or other path). However, the opening 82 maytake on one or more other suitable configurations, as desired.

In some cases, the housing 26 of the advancer assembly 16 may includeindicia on an outer surface 84 of the housing 26. As depicted in FIG. 4,the indicia, when included, may be positioned at predetermined and/orconsistent locations along the opening 82 to provide a user (e.g., aphysician or other user) with a measurement or other indication of anaxial position of the drive mechanism, the drive shaft 18, and/or therotational device 20. The indicia may be general tick marks,measurements (e.g., millimeters, centimeters, inches, etc.), and/orother suitable indicia that facilitate providing an understanding of arelative position of the knob assembly 23 and/or the drive mechanismalong the opening 82. Alternatively or in addition, other indicia may beprovided on the outer surface 84 of the housing 26.

FIG. 5 is a schematic cross-sectional view of a portion of the advancerassembly 16. FIG. 5 depicts the knob assembly 23 coupled to a drivemechanism 50. The depicted drive mechanism 50 is a pneumatic turbine,however, the drive mechanism may be a different pneumatic motor, may bean electric motor, and/or may include one or more other suitable drivemechanisms.

The knob assembly 23 may be coupled to the drive mechanism 50 in asuitable manner that facilitates movement of the drive mechanism 50 inresponse to movement of the knob assembly 23. For example, the knobassembly 23 may be coupled to the drive mechanism 50 with a friction fitconnection, a keyed fit connection, a snap fit connection, a threadedconnection, a luer lock connection, an adhesive connection, a weldconnection, a solder connection, a permanent connection, a releasableconnection, and/or one or more other suitable types of connection. Asshown in FIG. 5, an extension 53 of the slide adaptor 52 may extend intoa recess 51 of the drive mechanism 50 to form a keyed fit connectionbetween the knob assembly 23 and the drive mechanism 50 that may resultin movement (e.g., movement along a central axis) of the drive mechanism50 in response to movement (e.g., longitudinal movement) of the knobassembly 23.

As can be seen in FIG. 5, the inner threads 62 of the knob body 54 mayengage the outer threads 64 of the slide adaptor 52. As such, the knobbody 54 may be rotationally adjusted in a first direction to a firstposition to create a space between a bottom surface 86 of the knob body54 and the outer surface 84 to allow translation of the knob assembly 23along the predetermined path at least partially defined by the opening82 in the housing 26 of the advancer assembly 16, as indicated by arrows88. If it is desired to fix the knob assembly 23 and/or the drivemechanism 50 at a position along the opening 82, the knob body 54 may berotated in a second direction to a second position to bring the bottomsurface 86 of the knob body 54 into contact with the outer surface 84 ofthe housing 26 and create a friction fit coupling between the knob body54 and the housing 26 and prevent or limit longitudinal movement of theknob assembly 23, drive mechanism 50, drive shaft 18, and/or therotational device 20 relative to the housing 26. Although the knob body54 may be rotated to adjust an axial position of the knob body 54relative to the slide adaptor 52 and/or the outer surface 84 of thehousing 26, the engagement elements 58 of the slide adaptor 52 may beconfigured to engage with the shoulder 60 of the knob body 54 to limitseparation of the knob body 54 from the housing 26 and/or the slideadaptor 52.

As shown in FIG. 5, the actuator 56 may extend through the knob body 54,through an opening 90 (e.g., a central opening or other opening)extending at least partially through the slide adaptor 52, and alignwith the switch 72 (e.g., the second end 56 b of the actuator 56 mayalign with the button 78 of the switch 72). In such a configuration, theactuator 56 may be configured to axially translate and engage the button78 to send signal for adjusting a mode of operation of the drivemechanism. In one example, the first end 56 a of the actuator 56 mayextend out of the knob body 54 or may otherwise be accessible foractuation from exterior the knob body 54 such that a user may interactwith the first end 56 a of the actuator 56 to actuate the actuator 56(e.g., longitudinally translate) such that the second end 56 b of theactuator 56 engages the button 78 to actuate the switch 72.

As shown in FIG. 5, the protrusions 66 of the actuator 56 may bereceived in the opening(s) 70 of the slide adaptor 52. The opening(s) 70of the slide adaptor 52 and/or the protrusions 66 of the slide adaptor52 may be configured to allow and/or limit axial movement of theactuator 56 with respect to the slide adaptor 52 due to engagementbetween the protrusions 66 and the catch 68 of the slide adaptor 52.

FIG. 6 depicts a method 200 of operating a drive assembly 12 of anatherectomy system 10 to pass through an occlusion in a patient'svasculature. The method 200 may include releasing 202 a knob assembly(e.g., the knob assembly 23 or other suitable knob assembly) from afirst position (e.g., a fixed position) relative to a housing (e.g., thehousing 26 of the advancer assembly or other suitable housing). The knobassembly may be released from a fixed position by rotating a knob body(e.g., the knob body 54 or other suitable knob body) relative to a slideadaptor (e.g., the slide adaptor 52 or other suitable slide adaptor) toa second position (e.g., a released position) that facilitateslongitudinal translation of a drive mechanism (e.g., the drive mechanism50 or other suitable drive mechanism). Alternatively or in addition, theknob assembly may be released from a fixed position relative to thehousing in one or more other suitable manners.

When in a released position (as shown in the method 200 of FIG. 5) or afixed position, an actuator (e.g., the actuator 56 or other suitableactuator) may be actuated 204 to initiate an on mode, an off mode,and/or other mode of the drive mechanism. As discussed above, actuatingthe actuator may cause engagement with and/or actuation of a switch thatresults in sending a signal to a drive mechanism controller to change oradjust a mode of the drive mechanism. In one example, if the drivemechanism is in an off mode, actuation of the actuator may initiate thedrive mechanism entering an on mode. Similarly, if the drive mechanismis in an on mode, actuation of the actuator may initiate the drivemechanism entering an off mode.

With the drive mechanism in an on mode as a result of actuating theactuator (as shown in the method 200 of FIG. 5), when the drivemechanism is in the off mode, or before the actuator is actuated andwhile the knob assembly is in a released position, the knob assembly maybe longitudinally adjusted 206 (e.g., advanced or retracted). In somecases, a rotational device (e.g., the rotational device 20 or othersuitable rotational device) coupled to a drive shaft (e.g., the driveshaft 18 or other suitable drive shaft) may be advanced through apatient's vasculature to an occlusion while the drive mechanism is inthe off mode and then the drive mechanism may be actuated to an on modewhen the rotational device is adjacent the occlusion. After initiatingthe on mode of the drive mechanism, the knob assembly may be advanced206 such that the rotational device may engage the occlusion and borethrough the occlusion. Once the occlusion has been passed, the actuatormay be actuated 208 a second time to initiate entering the drivemechanism to an off mode. Once the procedure has been performed, theknob assembly may be rotationally adjusted to fix the knob assembly at aposition relative to the housing and the rotational device and the driveshaft may be removed from the patient's vasculature with the drivemechanism in the off mode. Alternatively or in addition, one or more ofthe steps of the method 200 may be repeated as needed to facilitatepassing the occlusion in the patient's vasculature.

Although not necessarily depicted in the FIGs., the methods describedherein (e.g., methods 100, 200, and/or other methods) may include one ormore steps other than those steps described herein and/or the describedsteps may be performed in one or more other orders, as desired unless anexpressly indicated otherwise. Moreover, the methods described hereinmay be repeated during operation of the atherectomy system 10 uponrequest or initiation, continuously, continuously at predeterminedintervals, and/or at other times.

Those skilled in the art will recognize that the present disclosure maybe manifested in a variety of forms other than the specific embodimentsdescribed and contemplated herein. For instance, as described herein,various embodiments include one or more modules described as performingvarious functions. However, other embodiments may include additionalmodules that split the described functions up over more modules thanthat described herein. Additionally, other embodiments may consolidatethe described functions into fewer modules.

Although various features may have been described with respect to lessthan all embodiments, this disclosure contemplates that those featuresmay be included on any embodiment. Further, although the embodimentsdescribed herein may have omitted some combinations of the variousdescribed features, this disclosure contemplates embodiments thatinclude any combination of each described feature. Accordingly,departure in form and detail may be made without departing from thescope and spirit of the present disclosure as described in the appendedclaims.

What is claimed is:
 1. An atherectomy device, comprising: a housing; adrive mechanism positioned within the housing and configured to coupleto an elongate member and rotate the elongate member upon actuation; aknob assembly in communication with the drive mechanism and operablyaccessible from exterior the housing, the knob assembly is configuredto: longitudinally translate to adjust an axial position of the drivemechanism; and be actuated to selectively adjust the drive mechanismbetween an on mode and an off mode.
 2. The device of claim 1, whereinthe knob assembly is configured to: longitudinally translate along afixed longitudinal distance; and releasably engage the housing to fixthe drive mechanism at a location along the fixed longitudinal distance.3. The device of claim 1, wherein the knob assembly comprises anactuator that is actuated to selectively adjust the drive mechanismbetween the on mode and the off mode.
 4. The device of claim 1, whereinthe knob assembly comprises: a switch configured to facilitate adjustingthe drive mechanism between the on mode and the off mode; and anactuator configured to engage the switch in response to being actuated,the actuator engages the switch to adjust the drive mechanism betweenthe on mode and the off mode.
 5. The device of claim 1, wherein the knobassembly comprises: a slide adaptor coupled to the drive mechanism; aknob body coupled to the slide adaptor and configured to releasablyengage the housing to fix the drive mechanism at an axial location alongthe housing; and an actuator configured to be actuated to selectivelyadjust the drive mechanism between the on mode and the off mode.
 6. Thedevice of claim 5, wherein the knob assembly comprises: a switchconfigured to axially translate with the drive mechanism and facilitateadjusting the drive mechanism between the on mode and the off mode; andwherein the actuator is configured to engage the switch in response tobeing actuated.
 7. The device of claim 6, wherein the knob assemblycomprises a printed circuit board in electrical communication with theswitch and coupled with the slide adaptor.
 8. The device of claim 6,further comprising: a control assembly configured to control power tothe drive mechanism; wherein the knob assembly comprises a printedcircuit board in electrical communication with the switch and configuredto axially translate with the drive mechanism, the printed circuit boardis in electrical communication with the control assembly.
 9. The deviceof claim 5, wherein the actuator is coupled to the slide adaptor andconfigured to translate with the drive mechanism between a first axialposition of the drive mechanism and a second axial position of the drivemechanism.
 10. The device of claim 5, wherein the knob body is coupledto the slide adaptor via a first connection and a second connection, theknob body is configured to be adjusted via the second connection toselectively engage the housing and fix the drive mechanism at the axiallocation along the housing.
 11. The device of claim 1, wherein the drivemechanism is a turbine.
 12. A method of actuating an atherectomy deviceof an atherectomy system, the method comprising: releasing a knobassembly from a releasably fixed position at a location on apredetermined path along a housing of the atherectomy device; actuatingan actuator of the knob assembly to initiate an on mode of a drivemechanism in the housing of the atherectomy device; and longitudinallytranslating the knob assembly on the predetermined path.
 13. The methodof claim 12, further comprising: when the drive mechanism is in the onmode, actuating the actuator of the knob assembly to initiate an offmode of the drive mechanism.
 14. The method of claim 12, wherein theactuator is actuated while the knob assembly is fixed at the location onthe predetermined path.
 15. The method of claim 12, wherein the actuatoris actuated while the knob assembly is released from the releasablyfixed position.
 16. The method of claim 12, further comprising: rotatinga knob body of the knob assembly until the knob body engages the housingof the atherectomy device to releasably fix the knob assembly relativeto the housing.
 17. An atherectomy device comprising: a drive mechanismconfigured to rotate an elongate member securable to the drivemechanism; a knob assembly comprising: a slide adaptor secured relativeto the drive mechanism; a knob body adjustably secured to the slideadaptor; and an actuator adjustably secured to the slide adaptor; andwherein the knob assembly is configured to longitudinally translate withthe drive mechanism and actuation of the actuator initiates a mode ofthe drive mechanism.
 18. The device of claim 17, wherein the knobassembly comprises: a switch in communication with the actuator suchthat actuation of the actuator adjusts the switch to initiate a mode ofthe drive mechanism.
 19. The device of claim 18, wherein the knobassembly comprises: a printed circuit board coupled to the slide adaptorand in electrical communication with the switch.
 20. The device of claim17, wherein: the knob body is adjustable between a first position thatfacilitates longitudinal translation of the drive mechanism and a secondposition that releasably fixes the drive mechanism at a longitudinallocation; and the actuator is actuatable to initiate a mode of the drivemechanism when the knob body is in the first position and when the knobbody is in the second position.